Application of Celiac Plexus Block in Postoperative Analgesia of Whipple Surgery

NCT05205720 | Completed Phase 4 DMC

• 1 other identifier: 2021-0594
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This subject intends to explore the value of intraoperative celiac plexus block in postoperative acute pain management and its promoting effect on patients' rapid recovery during Whipple surgery through a randomized controlled trial.

Conditions

Pain, Postoperative; Nerve Block

Keywords

celiac plexus block

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Morphine equivalent

  72 hours after surgery

Secondary Outcomes (13)

• Press of the analgesic pump

  Every 24 hours post-surgery for 72 hours

• Time to first flatus

  72 hours after surgery

• Length of postoperative hospitalization

  After surgery to before discharge, up to 2 months

• White blood cell count

  At the end of surgery and 24 hours post-surgery

• C-reactive protein

  At the end of surgery and 24 hours post-surgery

Study Arms (2)

NB group

EXPERIMENTAL

Celiac plexus block (CPB) was added to the postoperative analgesia plan. CPB: the target nerve is located in the retroperitoneal space, embedded in the fat in front of the aorta, and distributed in a network along the anterolateral wall of the aorta, just at the beginning of the celiac trunk. During direct vision (anterior) block, first expose the upper edge of the pancreas, palpate the abdominal aorta and abdominal trunk, and palpate the pulsation of the common hepatic artery and splenic artery at the level of the abdominal trunk. Use a 25g 6cm puncture needle with an extension tube and a syringe pumped back by an assistant to form a negative pressure, then the needle is inserted into the fat on both sides of the abdominal aorta. If there is no blood or fluid outflow, slowly inject 10ml of 0.5% ropivacaine each side. After pulling out the needle, observe whether there is damage and bleeding. If necessary, use low-energy electrocoagulation to stop bleeding.

Procedure: Celiac plexus block; Drug: Ropivacaine

GC group

NO INTERVENTION

The same analgesic plan as the experimental group, except that CPB is not performed.

Interventions

Celiac plexus block PROCEDURE

The surgeon is instructed to perform a single celiac plexus block under direct vision. 10ml 0.5% ropivacaine is injected into the nerve in both sides.

NB group

Ropivacaine DRUG

Mixed solution for nerve block, made of 0.75% ropivacaine (Naropin, Astrazeneca AB) diluted in different proportions.

NB group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18years;
• received open Whipple surgery.

You may not qualify if:

• patients unable to cooperate with evaluations;
• patients with history of drug abuse, local anesthetic allergy, anatomical variation of the celiac ganglia indicated by abdominal CT, abdominal aortic diseases;
• non-standard surgical procedures, planned postoperative ICU admission;
• American Society of Anesthesiologists (ASA) classification of 4 or 5.
• Withdrawal criteria:
• Patients who underwent unplanned surgeries, required reintubation or a second surgery, received ICU care within three days post-surgery, died within two weeks post-surgery, or experienced any unexpected events were withdrawn from the study.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• Li M, Fang L, Xing T, Wang C, Chen S, Yu S, Zhu J. A single-blind randomized controlled trial of celiac plexus block for analgesia after whipple surgery. BMC Anesthesiol. 2025 Apr 22;25(1):193. doi: 10.1186/s12871-025-03045-7.

  PMID: 40263988 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Minpu Li, Master

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 25, 2022
• Study Start: March 9, 2022
• Primary Completion: November 12, 2023
• Study Completion: November 12, 2023
• Last Updated: April 9, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: With publication

Locations

CN (1)